YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 216 drug applications between 19 April 2021 and 25 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 22 drug names.

2021/04/19 – 2021/04/25

Period
2021/04/19 to 2021/04/25, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
216
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
0

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

216filings, 35 of them generic

By application type

Application typeFilings
Supplement89
New drug50
Generic35
Import19
Import re-registration18
Unspecified5

By drug type

Drug typeFilings
Chemical drug147
TCM34
Therapeutic biologic34
Prophylactic biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4123
2Rivaroxaban Tablets323
3Afatinib Dimaleate Tablets322
4Ornidazole Injection210
5Obeticholic Acid Tablets210
6Pregabalin Capsules2112
7Ticagrelor Tablets2110
8Vitamin K1 Injection216
9Cabozantinib Tablets210
10Sodium Valproate Concentrated Solution for Injection110

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

116 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized24240
2AstraZeneca AB820
3Lilly France820
4Novartis Pharma Schweiz AG630
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD630
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
7Yan Tai Yuan Sheng Pharma Co., Ltd. romanized430
8Ling Ke Pharma (Hangzhou) Co., Ltd. romanized420
9Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized414
10Jiangsu En Hua Pharma Co., Ltd. romanized410

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

68 this week

AcceptedDrugApplicants
2021/04/23Import · Class 1 注射用Oregovomab · No verified English nameJXSL2101013 OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2021/04/23Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2101012 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd
2021/04/23Generic · Class 3 Ornidazole InjectionCYHS2101097 Kang Pu Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Ornidazole InjectionCYHS2101096 Kang Pu Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101086 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/04/23Generic · Class 3 Clonidine hydrochloride extended-release tabletsCYHS2101084 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2021/04/23Generic · Class 3 Obeticholic Acid TabletsCYHL2101005 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Obeticholic Acid TabletsCYHL2101004 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Vitamin K1 InjectionCYHL2101002 Hainan Brilliant Pharmaceutical Co., Ltd.
2021/04/23Generic · Class 3 Vitamin K1 InjectionCYHL2101001 Hainan Brilliant Pharmaceutical Co., Ltd.
2021/04/23Generic · Class 3 Butalbital, Acetaminophen, and Caffeine CapsulesCYHL2101000 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSS2101000 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2021/04/23New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2101039 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/23New drug · Class 1 ES102注射液 · No verified English nameCXSL2101038 Ke Wang (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/23New drug · Class 1 注射用LBL-015 · No verified English nameCXSL2101036 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2021/04/23New drug · Class 1 注射用IMM2902 · No verified English nameCXSL2101035 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/04/23New drug · Class 1 DF003注射液 · No verified English nameCXSL2101034 Suzhou Ding Fu Ba Dian Bio Technology Co., Ltd. romanized
2021/04/23New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2101033 Name not romanized; Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized
2021/04/23New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2101032 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/04/23New drug · Class 1 福瑞赛定片 · No verified English nameCXHL2101079 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 福瑞赛定片 · No verified English nameCXHL2101078 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 ASKC852片 · No verified English nameCXHL2101077 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 ASKC852片 · No verified English nameCXHL2101076 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 HS269片 · No verified English nameCXHL2101071 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 HS269片 · No verified English nameCXHL2101070 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 HS269片 · No verified English nameCXHL2101069 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 注射用HR20013 · No verified English nameCXHL2101068 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/04/23New drug · Class 1 WXSHC071胶囊 · No verified English nameCXHL2101067 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2021/04/23New drug · Class 1 WXSHC071胶囊 · No verified English nameCXHL2101066 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2021/04/23New drug · Class 1 WXSHC071胶囊 · No verified English nameCXHL2101065 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized

38 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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